Schizochytrium sp. (FCC-3204) oil: authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013: In accordance with Regulation (EU) No 609/2013
• Food supplements as defined in Directive 2002/46/EC for the general population above 3 years of age: 1 g/day
• Protein products, excluding dairy analogues: 1 g/100 g

Additional specific labelling requirements

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’ The labelling of food supplements containing Schizochytrium sp. (FCC-3204) oil shall bear a statement that they should not be consumed by infants and children under 3 years of age.

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

Description/Definition:

The novel food is an oil produced from the strain FCC-3204 of the microalgae Schizochytrium sp.

Composition:

Acid value: ≤ 0,5 mg KOH/g

Peroxide value (PV): ≤ 5,0 meq/kg oil

Moisture and volatiles: ≤ 0,05 %

Unsaponifiables: ≤ 4,5 %

Trans-fatty acids: ≤ 1,0 %

Docosahexaenoic acid (DHA): ≥ 32,0 %

p-anisidine value: ≤ 10

Source and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

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